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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead and coordinate CDIS deliverables for clinical trials, ensuring data quality, standards adherence, TMF documentation, inspection readiness, and oversight of Data Managers while partnering with cross-functional teams and external vendors to meet study timelines.
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
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Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Lead moderately complex digital projects, guide teams, drive process improvements, analyze product analytics and support trends, ensure regulatory-compliant deliverables, and contribute to digital strategy and roadmaps.
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Product AnalyticsSap Edoc Framework
Lead CDIS activities for assigned clinical trials, ensuring data standards, quality, inspection readiness and timely deliverables. Provide strategy, oversight and mentorship to Data Managers, coordinate Data Management Plans, select data acquisition standards and quality risk indicators, manage vendor/data due diligence, and collaborate cross-functionally to ensure regulatory and SOP compliance.
As part of the Clinical Data and Information Sciences (CDIS)group, an integral delivery unit within the Clinical Development & Operations (CD&O)organization, the Clinical Data Scientist is responsible for representing CDIS at the study team level. The Clinical Data Scientistis accountable for the coordination of all CDIS deliverables associated with a clinical trial, as well as adherence to data standards and the quality of the study data sets. The Clinical Data Scientist provides leadership, direction, and oversight to Data Managers working on the clinical trial and is accountable for the trial’s inspection readiness.
- Serve as Clinical Data Scientist for one or more clinical trials, assuming responsibility for all CDIS activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence.
- As a member of the Core Study Team, drive operational excellence in collaboration with cross-functional partners through the application of CDIS best practices at the study level; serve as technical resource on how to best collect, process, consume and report clinical trial data.
- They are accountable for the quality and timeliness of all CDIS deliverables in support of the clinical trial; They partner with Research/Business Units, external data/service providers and internal CDIS staff to deliver high-quality data management for all studies as assigned.
- Proactively drives quality and efficiency to meet study/asset timelines milestones, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team.
- Ensure work carried out by/on behalf of CDIS is in accordance with applicable SOPs and work practices; accountable for assuring adherence to regulations, standards, GCDMPs, ALCOA principles by the team they are coordinating.
- Ensure the required study-specific CDIS documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously.
- Work with Asset Leads to establish strategy, timelines, and adequate resourcing of the study.
- Provide leadership, direction and oversight to the CDIS resources working on the clinical trial(s).
Work Location Assignment: On Premise
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